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Introduction to Patient Safety Research Developing Solutions: Cluster Randomized Clinical Trial 2: Introduction: Study Details Full Reference

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introduction to patient safety research

Introduction to Patient Safety Research

Developing Solutions: Cluster Randomized Clinical Trial

2 introduction study details
2: Introduction: Study Details

Full Reference

Nielsen PE, Goldman MB, Mann S, et al. Effects of teamwork training on adverse outcomes and process of care in labor and delivery: a randomized controlled trial. Obstet Gynecol, 2007: 109:48-55

Link to Abstract (HTML)Link to Full Text (PDF)

3 introduction patient safety research team
3: Introduction: Patient Safety Research Team

Lead Researcher - Col. Peter E. Nielsen, MD

Chairman, Department of Obstetrics and Gynaecology,

Madigan Army Medical Center in Tacoma, WA, USA

Field of expertise: patient safety, team training, labour management

Other team members:

Marlene B. Goldman, ScD

Susan Mann, MD

David E. Shapiro, PhD

Ronald G. Marcus, MB, BCh

Stephen D. Pratt, MD

Penny Greenberg, RN

Patricia McNamee, RN, MS

  • Mary Salisbury, RN, MSN
  • David J. Birnbach, MD
  • Paul A. Gluck, MD
  • Mark D. Pearlman, MD
  • Heidi King, MS
  • David N. Tornberg, MD, MPH
  • Benjamin P. Sachs, MB, BS
4 background opening points
4: Background: Opening Points

In the 1980s, US Department of Defense (DoD) developed crew resource management (CRM) training to improve the safety of air operations

Crew resource management: “error management capability to detect, avoid, trap or mitigate the effects of human error and therefore prevent fatal accidents.”

CRM attempts to capitalize on the ability of each crew (team) member to see, analyze, and react to the same situation in ways that reduce the potential for error

5 background study rationale
5: Background: Study Rationale

US Institute of Medicine reports suggest that implementing team training could reduce medical errors and improve patient safety

DoD has a long-standing interest in evaluating the concept of CRM as a teamwork tool to reduce human errors in medicine

Early prospective observational studies with multiple military and civilian hospitals showed promise for improving patient safety

Obstetrics provides a good setting to test this teamwork tool

Labor and delivery environment requires intense, error-free vigilance and effective communication between many different clinical disciplines

Delivery is the number one admission diagnosis in DoD hospitals

6 background setting the research team
6: Background: Setting the Research Team

MAMC Department of Obstetrics and Gynaecology approached by the DoD Patient Safety Office

Madigan Army Medical Center (MAMC) previously participated in a pilot project on team training in the Emergency Department

MAMC collaborated with Beth Israel Deaconess Medical Centre (BIDMC) in Boston to perform the study

Research expertise drawn from combined staff of MAMC and BIDMC, as well as from patient safety experts within national organizations


Obtained through the DoD Patient Safety Office of the Tricare Management Activity (TMA)

7 methods study design
7: Methods: Study Design

Design: cluster-randomized clinical trial

Intervention was a standardized teamwork training curriculum based on CRM that emphasized communication and team structure


To evaluate the effect of teamwork training on the occurrence of adverse outcomes and process of care in labor and delivery

8 methods study population and setting
8: Methods: Study Population and Setting


Hospital labour and delivery units at 15 US hospitals

1 307 labor and delivery room personnel trained


All women with a pregnancy of 20–43 weeks of gestation from December 31, 2002 to March 31, 2004

28,536 deliveries analyzed in intervention hospitals

Data collection completed for 94.4% of deliveries at control hospitals and 95.9% of deliveries

9 methods study recruitment
9: Methods: Study Recruitment

A balanced, masked randomization scheme at the hospital level

Assigned seven hospitals to receive a teamwork-training curriculum and eight hospitals to a control arm

All possible allocations of the hospitals to two arms balanced for hospital type and funding level

Trial was not blinded, with personnel at each site aware of their assignment to either the intervention or control arm

10 method study administration
10: Method: Study Administration

Clinical staff from the seven intervention hospitals attended an instructor training session

Coordination Course based on crew resource management and a curriculum used in hospital emergency and obstetric departments

Trainers returned to their respective hospitals to conduct onsite training sessions for obstetrics, anesthesiology and nursing staff

Structured each unit into core work teams and coordinating teams

Result: multidisciplinary contingency team of experienced physicians and nurses trained to respond in a coordinated way to obstetric emergencies

11 methods data collection
11: Methods: Data Collection

Data collection was divided into two periods:

Baseline: two months before teamwork training

Post-implementation: five months after the teamwork curriculum was adopted

All staff training occurred after baseline data collection period

Data collected during and immediately after delivery under the supervision of centrally trained data coordinators

12 methods outcome measures
12: Methods: Outcome Measures

Adverse Outcome Index developed to capture the proportion of all deliveries with at least one undesirable outcome and to serve as the primary response variable

Adverse Outcomes Index defined as the number patients with one or more adverse outcome divided by the total number of deliveries

A second weighted index outcome measure, the Weighted Adverse Outcome Score, developed to assess the occurrence, number and relative severity of outcomes

13 methods data analysis and interpretation
13: Methods: Data Analysis and Interpretation

All analyses conducted at the hospital level according to a pre-specified written analysis plan

Primary analyses performed to assess the effectiveness of the intervention were cluster-level analyses of covariance

during the baseline and post-implementation periods were summarized and compared using group means in the implementation and control arms

Baseline characteristics of the hospitals and the patient populations,

Hospital-specific values of the outcome measures and process measures


Intracluster correlation coefficients for the outcome measures and each process measure for all 15 hospitals

14 results key findings
14: Results: Key Findings

At baseline, there were no differences in demographic or delivery characteristics between the groups

Mean Adverse Outcome Index prevalence was similar in the control and intervention groups

Both at baseline (9.4% vs 9.0%) AND

After implementation of teamwork training (7.2% vs 8.3%)

One process measure, time from the decision to perform an immediate cesarean delivery to the incision, differed significantly after team training (33.3 minutes vs 21.2 minutes)

15 conclusion main points
15: Conclusion: Main Points

Training, as conducted and implemented, did not confer a detectable impact in this study

Adverse Outcome Index could be an important tool for comparing obstetric outcomes within and between institutions to help guide quality improvement

Further need for implementation and evaluation of teamwork training programs in obstetrics

Developing a set of uniformly defined outcome and process measure will provide a foundation for future trials to improve patient care

16 conclusion discussion
16: Conclusion: Discussion

There are a number of possible explanations for why this study did not demonstrate a significant impact on defined measures

Training may not have been effective

Team work that results in a detectable impact my require more training time and time to develop expertise

Measures chosen may not teamwork behaviour or medical errors in obstetrics

17 conclusion study impact
17: Conclusion: Study Impact

Academic impact

Provided a basis to further discuss how to implement and measure the effects of teamwork training in medicine

Policy impact

Implemented integration of multiple disciplines participating in handoffs and included a common language

Practice impact

Provided a basis for patient safety teamwork training in all DoD hospitals

Patient impact

Demonstrated improved response time for emergent Cesarean delivery

18 conclusion practical considerations
18: Conclusion: Practical Considerations

Study durations:

Approximately 66 months


About $250,000 USD

Required resources

Use of data management company as third party to ensure data integrity, and statistician with expertise in design protocol

Required competencies

Patient safety experts from a wide variety of specialties that care for women in labour

No ethical approval required

19 author reflections lessons and advice
19: Author Reflections: Lessons and Advice

If you could do one thing differently in this study, what would it be?

"Quantify the team’s ability to make behaviour changes and increase the intervention duration."

Advice for researchers:

Consider using the US Agency for Healthcare Research and Quality, Department of Health and Human Services and US Department of Defense team training program known as TeamSTEPPS (Team Strategies and Tools to Enhance Performance and Patient Safety).

20 author reflections lessons and advice 2
20: Author Reflections: Lessons and Advice (2)

Research is adaptable to developing countries’ settings

"Bring together stakeholders involved in caring for women in labor and develop consensus for implementing team training."

Ideas for future research:

Combine team training with simulation tools/devices directly on medical units

Evaluate incorporation of best clinical practice and debriefing for teamwork behaviour to reduce adverse outcomes

21 author reflections overcoming barriers
21: Author Reflections: Overcoming Barriers

Initial problems included coordination and approval of the protocol with each individual Institutional Review Board (IRB) and agreement on adverse clinical outcomes

Addressed with meticulous attention to detail in writing protocol, diligent work on the part of the Principle Investigator at each site

Other major problems were in study design and determining the power analysis

Agreement on which clinical outcomes to use required a panel of experts from a variety of disciplines and organizations in order to come to an agreement

22 author reflections alternative designs
22: Author Reflections: Alternative Designs

Funding constraints and practical implementation influenced study design requirements. Research team also considered:

Splitting labour and delivery units into two arms: intervention and control

However, crossover of staff and potential confusion on the unit precluded this design

Placing observers on labour and delivery to provide feedback on compliance with teamwork behaviours as well as record errors and/or near misses

Funding constraints precluded placing observers on labour units

23 additional resources
23: Additional Resources


TeamSTEPPS CD-ROM and DVD Multimedia Curriculum Kit from the AHRQ Publications Clearinghouse at 1-800-358-9295 or